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this video guidance represents OHRP s.current thinking on this topic at the.time of production and should be viewed.as recommendations unless specific.regulatory requirements are cited the.use of the word must in OHRP guidance.means that something is required under.HHS regulations at 45 CFR part 46 the.use of the word should in OHRP guidance.means that something is recommended or.suggested but not required an.institution may use an alternative.approach if the approach satisfies the.requirements of the HHS regulations at.45 CFR part 46.hi dr. Mitchell thank you so much for.taking the time to meet with me is this.still a good time for us to talk.absolutely.thank you I just had a few questions.that I wanted to go over with you about.this protocol that I'm about to submit.to the IRB for review.sure no problem and by the way thank you.very much for dropping it off yesterday.so that I had a chance to go over the.protocol and the informed consent.document I looked at them last night.what can I help you with today well as.you know this is a randomized.double-blind placebo-controlled study of.the effects of memoride on the cognitive.function in subjects with schizophrenia.and the purpose of this study is to test.whether memoride improves the memory.subjects with schizophrenia will be.admitted to the hospital for.approximately two weeks and during the.first week of the study subjects will.undergo a physical exam psychological.and cognitive testing and an MRI of the.brain during the second week of the.study subjects will receive either.memoride or a placebo three times a day.for seven days and also during the.second week they will be doing an.extensive series of cognitive tests to.help us establish whether or not the.subjects memory is improving they will.also receive a second MRI at the end of.the second week tell me well subjects.need to come off of their medications to.be eligible for this study as you are.well aware taking someone with.schizophrenia off of their medications.could potentially make their symptoms.worse right actually no we will not.memoride will be added on to their.current medications so my question is as.the study will be focused on subjects.with schizophrenia and a main symptom of.their disorder is psychosis and/or a.thought disorder.if subjects are unable to give informed.consent what are my options well let's.just take a look at the regulations here.the regulations specifically state that.no investigator may involve a human.being as a subject in research covered.by the regulations unless the.investigator has obtained the legally.effective informed consent of the.subject or the subjects legally.authorized representative so one option.is that if you felt the subject.could not give his or her own consent.you could discuss with the IRB the.possibility of having the subjects.legally authorized representative give.consent okay so if I did it that way I.think I would include the caveat that.should the subject regain or develop.their own capacity to consent then his.or her consent must be obtained for any.further research that's a great idea and.it certainly makes sense so it sounds.like you would want to come up with a.way to determine if a subject has the.capacity to give informed consent now.perhaps this is something you could.consult about with some of your.colleagues with respect to options for.dealing with that issue and if subjects.are found to be unable to give their own.informed consent you could either have.their legally authorized representative.consent for them or another option as.you can decide that if they do not have.the capacity to give their own informed.consent then they simply could not.participate in the study now of course.if you chose to exclude subjects that.lack the capacity to give informed.consent you would want to consider if.that would affect the overall validity.of the study and you and your team.should think about what you think would.be most appropriate presented to the IRB.for its consideration and then of course.the IRB would make the final.determination in that regard okay well.those are both really good ideas thank.you very much.are there other aspects of them from.consent that I should be mindful of.that's an excellent question and the.answer is yes the regulations state that.prospective subjects or the.representative must have a sufficient.opportunity to consider whether or not.they wish to participate okay well I.plan on sending the informed consent.document to prospective subjects prior.to meeting with them and of course will.give them ample opportunity to ask.questions and to think about whether or.not they would like to participate when.I meet with them in person okay that.sounds great.you also want to ensure that the.possibility of coercion or undue.influence would be minimized and as you.know the informed consent must be in a.language that is understandable to the.subject or the representative and there.can be no Excalibur Tory language used.in the consent okay well I'll be sure to.double check them from.process to make sure that it meets these.requirements thanks so much for taking.the time to meet with me it was very.helpful and instructive oh it's been my.pleasure please feel free to stop by.anytime thank you have a great weekend.you too there hi mr. Smith thank you so.much for coming in today I wanted to.spend a little bit of time talking to.you about your possible participation in.the study well thank you for inviting me.dr. Presley I'm glad to be here.sure um so a few weeks ago I sent you a.copy of the informed consent document.did you receive it and if so did you get.a chance to read it yes I brought it.with me I did get a chance to read it.over when I got it in the mail Thanks.great um did you have any questions.about what you've read so far so far I.think I'm okay but I might have.questions as we go along okay that's.totally fine so the first thing I would.like to emphasize is that the informed.consent process is actually a process.it's not just having you sign this.document today so this means that we'll.be providing with information throughout.the study and you should always feel.free to ask questions at any time even.after the study is over okay that's good.to know.okay well let's get started then.although I know that you've already read.them from consent document I'm going to.go over it again with you to just be.sure that we all feel comfortable with.what's been explained to you and then.all of your questions have been answered.and then at that point you'll have the.opportunity to take all the time that.you need to decide whether or not you'd.like to participate this data sounds.good okay so first of all we want you to.understand that this study involves.research and research is very different.from the clinical care that you receive.from your regular psychiatrist in the.community your regular doctor is.treating you and is giving you care.based on known scientific facts and in.this study we're asking a question that.we don't yet know the answer to well I.think I understand that because I've met.with my psychiatrist before I came here.and he explained to that to me okay.great.well now I'd like to move on and give.you a little more information about the.study so the purpose of the study is to.see if memoride improves memory the.ability to concentrate and problem-solve.and people with schizophrenia that's.great because I sometimes have problems.with those symptoms I have trouble with.concentrating sometimes I have trouble.with my memory so it would really.benefit me a lot.to be in the study well again we don't.know if this will work or not and that's.why we're doing the study and we don't.want you to have the misconception that.this drug is going to improve that.problem because at this point we don't.know whether it will or not and although.you might not benefit from the study.directly you will be contributing to.determining if this drug improves.cognitive abilities and people who have.schizophrenia well I guess even if I.don't benefit then I'm glad that other.people might benefit to have.schizophrenia so that's a good thing.well we appreciate that as you know this.is an inpatient study which means that.you will be staying in this hospital on.the research unit while you're in the.study the study will last for.approximately two weeks and we do.realize that two weeks is a long time to.be in the hospital but as long as your.symptoms are under control and that we.feel that you are safe the staff will.take you off the unit during the day to.participate in a variety of activities.that's good to know will there be any.games or computers on the unit for me to.use actually yes there is a computer and.a TV with some video games so good.because otherwise I think I might get a.little bored because it's two weeks very.understandable so okay so let me move on.and tell you a little bit about the.study design so this study is called a.double-blind placebo-controlled study.and I realize that's very much of a.mouthful so let me try and break that.down a little bit for you okay so do you.know what a placebo is umm isn't it like.a sugar pill or a fake pill or something.like that right that's about right so.the placebo pill will look the same as.the pills containing memoride but it.won't have any memoride in it so the.second part is the double-blind study.part which means that neither you nor.the research team know if you're taking.the study drug or the placebo so this is.a very common type of research design as.it helps researchers avoid being biased.when assessing study subjects right but.that's kind of scary will anybody know.if I'm taking the drug or not definitely.yes the pharmacists will know the.pharmacists and if there's ever any.problem all we need to do is call down.to the pharmacy and they can break the.blind okay which means that they'll tell.us if you're on the study drug or not.and if that happens will I then have to.come off the study or um yes actually.once the blind is broken we would take.you out of the study I see okay so.finally let me explain the last part of.that which is randomized so let me.explain what randomized mean I think I.know what that means already isn't it.like when you flip a coin so I might.either go on the drug if I get it heads.or tails I might not go on the drug and.get the placebo exactly so you're going.to have a 50/50 chance of being on the.study drug okay so let's move in and.talk a little bit now about what.procedures are going to be are taken if.you join the study okay okay so once the.study begins you'll be asked to take.some psychological and cognitive exams.that will test your ability to pay.attention problem-solve and remember.things.okay so during that first week you'll.also have an MRI of your brain as well.as a physical exam in the second part of.the study the second week you'll be.given either memoride or placebo that.looks like imma ride three times a day.for seven days okay okay so will I still.be on the medications that I'm currently.on or will I have to come off of those.no you will still continue to take your.medications that your psychiatrist.already puts you on and the memorizer.the placebo will be added on to those.medications okay so moving along you.will also be given some more cognitive.tests as well as the second MRI towards.the end of the second week and then two.weeks after you actually finished the.study we will call you at home to follow.up with you to make sure that you.haven't had any additional side effects.or problems and to answer any additional.questions that might have come up for.you at that time so sounds good okay so.do you have any questions about what.I've told you that sounds really great.but I'm wondering if the drug really.works for me.can I get the drug when I go off the.study can I start it up again we would.welcome you to share that with the.results of the study with your personal.psychiatrist so that together you can.make an appropriate decision regarding.your care okay.so do you have any other questions at.this point well I'm kind of worried.about insomnia because sometimes I have.trouble sleeping is this one of the side.effects of memoride well there are a.number of risks from participation in.the study which include possible side.effects from memoride so the side.effects that have been reported for this.medication include nausea.and the lack of appetite insomnia is not.a known side effect but it is possible.that you might have a different reaction.to it that is yet unknown okay so there.are a few other possible risks from.participation in the study and as I.mentioned you will be doing some.cognitive testing however this will be.done at a relaxed pace but it's possible.that taking the test might produce some.discomfort from you're feeling anxious.or nervous so these tests can usually be.completed in about 75 to 80 minutes and.if it becomes too difficult we can stop.okay what about the MRI isn't there risk.associated with the MRI there are some.minor risks associated with getting an.MRI for example you'll be asked to lie.on your back for about an hour and it.might get uncomfortable for you to lie.still for that long in addition the MRI.machine makes a lot of noise but we'll.give you some earplugs that will.hopefully help with that also some.people get claustrophobic from being in.the MRI scanner do you do you know what.claustrophobia enix so isn't it like.when people freak out if they're in.really tight spaces right that's correct.some people get very anxious or might.even have a panic attack so has that.ever happened to you no that's never.happened to me so I think I'm okay okay.that's good to hear.also because an MRI is a very large.magnet it has the ability to move or.attract metal so before you enter into.the room with the MRI scanner we would.ask you to remove all jewelry and if you.have any metal in your body like metal.plates or shrapnel or a pacemaker for.example we would not allow you to have.the MRI as it could place you at risk.gotcha well I don't have any metal in my.body so I could be fine good and well.thanks for letting us know that so as I.mentioned earlier you will have a full.physical exam before participating in.the study so we'll go over to your.entire medical history in order for us.to know more about your health so I also.wanted to mention again that.participation in the study is not.designed to benefit you directly however.the information that we learned from the.study might help people with.schizophrenia in the future yes I.understand that what happens if I decide.not to participate well one alternative.to participating in the study is not to.participate also not participating or.withdrawing from the stay would not.exclude you from possibly participating.in other stud.that we have or from things that you.would otherwise be entitled to such as.medical care so will my psychiatrist or.any one of my family members be able to.review my research records No.all of your information will be kept.confidential unless you request in.writing that the information be released.to a particular person or persons well I.think that sounds pretty reasonable I do.have one other question.I noticed somewhere in the informed.consent there was something about.getting payments for participation can.you talk a little more about that.sure yes there is a small amount of.compensation which will hopefully cover.your transportation and some other minor.expenses that you might incur from.participation in the study and besides.these costs we don't foresee you having.any additional costs associated with.this study so how much will I get well.the compensation is broken up into three.parts so for the first week of the study.you'll receive $50 for the second part.of the study when you'll be getting.either the study drug or the placebo.which again I mentioned is a sugar pill.you'll receive one hundred and fifty.dollars and if you get the MRI scans.you'll receive an additional $150 so if.you complete the entire study you would.get a total of three hundred and fifty.dollars well that does sound like a lot.of money but I guess I'm really doing it.for different reasons well we we.appreciate that also I wanted to inform.you that if you do sustained an injury.during the time that you're.participating in the study that's.related to your being in the study will.provide short-term care at no cost to.you does that include anything that.might happen if I have side effects from.the medication yes it includes any.problems that you have while you're in.the study that are related to your.participation in the study and also if.you do have any problems it's really.important that you immediately let the.nurses or the doctors know and their.nurses on the unit 24 hours a day so.someone will always be there to help you.okay and in addition if you need to.reach me as you see here on the consent.form there's my phone number and my.pager number so I can call you anytime.yes that's definitely oh yeah that's.great and separate but related you'll.also find the name and the phone number.of the patient advocate the subject.advocate so feel free to contact her if.you have any questions or concerns that.you don't feel comfortable talking to.the research team about she really nice.she is very nice.studious so do you have any questions um.I think I'm very interested in.participating in the study okay it's.something that I think is going to be.help other people and I'd really like to.help out okay so I know I've told you.this a few times already but I just.wanted to remind you that participation.in the study is entirely voluntary and.that you may choose not to take part or.you may end your participation in the.study at any time and there would be no.penalty for doing so and I want to.emphasize that withdrawing from the.study would not make you lose any.benefits to what you are otherwise.entitled okay that sounds fine okay.so there was one last thing that I.wanted to mention that is related to a.throwing from the study so not only can.you stop the study at any time but I can.stop it too so for example if your.symptoms worsen to the point that we.feel it's no longer safe for you to.continue in the study we would withdraw.you from the study at that point or if.we get information about newly.discovered side-effects from the study.drug we may stop the study then too so.it's important that you know that your.safety is always more important than the.research well it's good to know that.you're looking out for me so I.appreciate that.sure well now that we've gone over the.information about the study have you.made a decision about whether you'd like.to participate or would you like to have.some more time to think it over I think.I have had enough time I would like to.participate I think it would be very.interesting and I think it would be.helping other people out so I would like.to great well we very much appreciate.your willingness to be part of our study.and again at any time if you change your.mind just let us know so since you've.read over the consent form and if you.have no further questions I'd like to to.ask you to sign the document and as a.reminder signing the informed consent.document is acknowledging that the.information in the consent form has been.explained to you and that you've been.given that opportunity to discuss it and.ask questions and that you do indeed.consent to take part in the study okay.so where do I sign right here here's a.pen okay.great well again I want to thank you for.agreeing to be a part of the study and I.very much look forward to working with.you I think it'll be interesting Thanks.great well thanks a lot so I'll be right.back I'm just going to go make a copy of.this consent form before you are we.

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